An ostomy placement as, for example, gastrostomy, jejunostomy, colostomy, ileostomy is utilized in medical profession for feeding patients with impaired swallowing but intact gut function as well as for decompression of overdistended hollow organs. While it is possible to create the ostomy by surgical procedure, recently less invasive endoscopic or fluoroscopic methods of percutaneous ostomy tube placement are widely employed. The percutaneous endoscopic gastrostomy (PEG) tube placement is one of the most commonly used prototypes of the ostomy placement.
The percutaneous endoscopic gastrostomy (PEG) tube placement, as it is described in U.S. Pat. No. 6,808,519, “involves introduction of a gastroscope into the stomach, while desired site where the stoma is to be created is indicated from above by depressing the abdomen. A sheathead needle punctures the abdominal wall and enters the stomach, creating the stoma. The needle is removed and a looped insertion wire is introduced through the sheath where it is grasped by a snare deployed from the working channel of the gastroscope. Once it is captured, the insertion wire is pulled into the channel of the gastroscope. The gastroscope is then withdrawn from the patient via the oral cavity, pulling the wire with it. In the standard Ponsky method (or “pull” method), the distal loop of a percutaneous gastrostomy feeding tube is coupled to the insertion wire loop exiting the patients mouth. With the insertion wire now tethered to the gastrostomy feeding tube, the endoscopist then retracts the insertion wire exiting the stoma, thereby pulling the gastrostomy feeding tube into the patient's mouth and on toward the stomach. The tapered dilator portion aids in allowing the gastrostomy feeding tube to pass through the stoma. Once the tube has been properly positioned with the end cap snugd against the internal wall of the stomach, the dilator portion of the gastrostomy feeding tube is cut away.” This technique was described initially by Jeffrey L. Ponsky and Michael W. L. Gauderer in “Percutaneous endoscopic gastrostomy: a nonoperative technique for feeding gastrostomy”, Gastrointestinal Endoscopy, Vol. 27, N0 1, 1981, pp 9-11. In addition to above steps in the Ponsky and Gauderer references cited above, “another rubber bumper is prepared and is positioned on the catheter (feeding tube) as it emerges from the abdominal wall”. “Rubber bumper” placed over the feeding tube, also known as external retention member, is slidably movable and frictionally retained over feeding tube. Once the feeding tube is secured in place, the Y-port adapter is connected to it.
Various types of gastrostomy tube devices were employed for percutaneous insertion by above “pull” method. Most gastrostomy tube devices, including commercially available from Wilson-Cook Medical Inc., Winston-Salem, N.C. or Boston Scientific Corporation, Watertown, Mass., comprise a tubular body having an internal retention member secured at one end, a dilator portion integrally attached at an opposite end, and a pull loop integrally formed and projecting outwardly from the dilator tip.
The percutaneous gastrostomy tube devices are preferably supplied in a kit form additionally including a guide wire, a needle catheter, an external retention member having a bore, and a snare.
There are problems associated with all three components (device, kit, method) of the above prior art technique. For example:
1. Commercially available gastrostomy tube devices with the dilator portion integrally attached to tubular body require sharp devices such as scissors or knife to cut away the dilator portion or the pull loop.
2. A gastrostomy tube device described in the Ponsky and Gauderer references cited above requires the time consuming assembly of several separate components in preparation for the operation. This also requires scissors or knife to cut off suture placed through the end of feeding tube. Alternatively time and effort are required to untie abovementioned suture from “guide-wire”, pull off cannula, and remove stitch passed through the end of feeding tube. Additionally placing the suture through the end of the feeding tube may result in partial or complete cutting through that end the feeding tube. This is especially true in cases of significant pull forces used.3. The external retention member of the prior art is difficult to engage over the end of gastrostomy tube because of a smaller size of the bore.4 The external retention member of the prior art is difficult to move along hollow flexible tube for 30-60 cm because of sliding friction.5. The external retention member of the prior art is difficult to position accurately at abdominal surface level because of sliding friction6. The guide-wire in the methods of the prior art is first pulled through the abdominal wall access to the mouth, to be then pulled from mouth to and through the abdominal wall access.7. Use of the snare or any other grasping device suitable for passing through an endoscope is associated with several problems:a) time and effort are required to advance the snare through about 130-150 cm long working channel of endoscope;b) time and effort are required to remove the snare from about 130-150 cm long working channel of endoscope;c) capturing of the guide-wire with a snare is complex maneuver requiring coordination of simultaneous movement of endoscope and snare in different direction;d) an additional assistant is used to open and close the snare;e) a snare occupies a lot of space in percutaneous gastrostomy kits;i) a snare adds a cost to percutaneous gastrostomy kits.
Present invention has various advantages over and addresses several of the shortcomings of previously described techniques:
1. Provides secure and releasable attachment between the hollow flexible tube, the pull-loop member, and the tapered cannula. This attachment is strong enough and, at the same time, easy to disengage.
2. Eliminates the need of sharp devices such as scissors or knifes to cut the hollow flexible tube, or a pull-loop member to release the hallow flexible tube.
3. External retention member coupled with tubular device is easy to engage over the end of the hollow flexible tube.
4. External retention member coupled with tubular device is easy to move along the hollow flexible tube.
5. Use of a tubular device with side opening provides an accurate positioning of the external retention member.
6. Use of a wire-loop device eliminates steps of pulling the guide-wire through abdominal wall access to the mouth.
7. Use of the wire-loop device eliminates complex step of capturing the flexible guide wire by snare device.
8. Use of the wire-loop device eliminates the need of using the snare or any other grasping device suitable for passing through an endoscope, whereby:
a) saves time and effort required to advance the snare through about 130-150 cm long working channel of endoscope,
b) saves time and effort required to remove the snare from about 130-150 cm long working channel of endoscope,
c) eliminates the need of the assistant to open and close the snare,
d) saves the space in percutaneous gastrostomy kits,
e) reduces the cost to percutaneous gastrostomy kits,
These and further objects and advantages of the present invention will become more apparent upon reference to the following drawings, ensuing description and appended claims.